Supporting the Well Being of Families of Young Children With Autism Spectrum Disorders

Supporting the Well Being of Families of Young Children With Autism Spectrum

The objective of this 2 year research project is to determine whether an evidenced-based empowerment strategy, Problem Solving Education (PSE), targeted to mothers of young children with autism spectrum disorders (ASDs), promotes family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning. We propose a randomized control trial involving 140 mothers who have children <4 years with confirmed ASDs. Based on the paradigm of the IOM report on mental health prevention research that highlights the importance of targeting interventions to at-risk populations who may not meet diagnostic criteria, all mothers of young children with ASDs will be eligible to participate. Consistent with previous studies of cognitive-behavioral interventions, the mother-child pairs will be followed for 9 months. The intervention will be embedded in two settings that provide services to young children with ASDs - Early Intervention (EI) programs and specialty developmental assessment clinics. We aim to support families during a critical juncture - when they are confronted with a new diagnosis and are asked to navigate a complex service system on their children's behalf. The hypothesis of this proposal is that strengthening problem solving skills among mothers of young children with ASDs serve as an important buffer against the negative impact of life stressors, and thereby prevent and attenuate depressive symptoms and parenting stress.

Study Overview

• Status: Completed
• Conditions: Maternal Depression
• Intervention / Treatment: Behavioral: Problem Solving Education

• Study Type: Interventional
• Enrollment (Actual): 122
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02118
      • Boston Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• all mothers of young children </ 6 with ASDs
• mothers who speak English or Spanish

Exclusion Criteria:

• Mother has psychosis
• Mother endorses suicidal ideation
• Mother actively using illicit drugs
• Mother expected to leave area within 6 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Problem Solving Education	Behavioral: Problem Solving Education; Problem Solving Education (PSE) is an evidenced-based empowerment strategy, targeted to mothers of young children to promote family well-being by decreasing the burden of maternal depressive symptoms and maternal parenting stress and improving social functioning.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quick Inventory of Depressive Symptoms	Baseline, 1.5, 3, 4.5, 6, 7.5 & 9 months
Parenting Stress Index	Baseline, 3, 6 & 9months
Perceived Stress Scale	Baseline, 3, 6 & 9 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Social Problem Solving Inventory	Baseline, 3, 6 & 9 months
Social Adjustment Scale Self-Report	Baseline, 3, 6 & 9 months
Patient Activation Measure	Baseline, 3, 6 & 9 months

Collaborators and Investigators

• Sponsor: Boston Medical Center
• Collaborators: HRSA/Maternal and Child Health Bureau

Publications and helpful links

General Publications

• Feinberg E, Augustyn M, Fitzgerald E, Sandler J, Ferreira-Cesar Suarez Z, Chen N, Cabral H, Beardslee W, Silverstein M. Improving maternal mental health after a child's diagnosis of autism spectrum disorder: results from a randomized clinical trial. JAMA Pediatr. 2014 Jan;168(1):40-6. doi: 10.1001/jamapediatrics.2013.3445.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): March 1, 2013

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 27, 2009
• First Posted (Estimate): November 30, 2009

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Depression,; Early Intervention,; Behavior Disorder,; Parenting Skills,; Children with Special Health Care Needs,; Developmental Disabilities,; Family Support Programs
• Additional Relevant MeSH Terms: Behavioral Symptoms; Depression
• Other Study ID Numbers: H-28799